VOLCANO CORPORATION

FDA Device Registration & Listing · Rancho Cordova, CA, US · Registration 2939520

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
2939520
FEI Number
2939520
Entity Name
VOLCANO CORPORATION
City/State/Country
Rancho Cordova, CA, US
Establishment Address
2451 Mercantile Drive, Rancho Cordova, CA 95742, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Philips Medical Systems International BV (Owner Number: 2939520)
Owner / Operator Contact Address
Veenpluis 6, Best, NL-NOTA 5684PC, NL
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K170385
PMA Number
N/A

All Registered Proprietary Names

Software v3.5 IntraSight Plus Sterile Equipment Covers Visions PV 18 Digital IVUS Catheter OmniWire Pressure Guide Wire Reconnaissance PV 18 OTW Digital IVUS Catheter R-100 Automatic Pullback Device 300000629191, Upgrade Kit, SyncVision v4.1 Visions PV 14P RX Digital IVUS Catheter OmniWire Pressure Guide Wire Upgrade Kit, SyncVision v4.2 IntraSight Mobile System 806426-008 – ComboMap Software v1.9 Document Kit 806426-012 – ComboMap Software v2.1 Upgrade Kit 803523-001 – ComboMap Cart Kit 806426-004 – ComboMap Software v1.9 Upgrade Kit 807062-001 – ComboMap Sterile Cover 803521-001, 802745-001 – ComboMap System SyncRx SyncVision System s5i Visions PV 35 Digital IVUS Catheter Visions Pioneer Plus Catheter Phoenix Atherectomy System 2.2mm x 149cm Phoenix Atherectomy System 1.8mm x 149cm Phoenix Atherectomy Catheter 1.8mm x 149cm Phoenix Handle with Wire Support Clip Phoenix Atherectomy Catheter 2.2mm x 149cm IntraSight CORE M2 Vascular System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DSK Computer, Blood-Pressure Cardiovascular Class 2 870.1110 2016-01-14
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2016-01-14
DSA Cable, Transducer And Electrode, Patient, (Including Connector) Cardiovascular Class 2 870.2900 2016-01-14
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2026-04-30
OWB Interventional Fluoroscopic X-Ray System Radiology Class 2 892.1650 2026-04-30
DSK Computer, Blood-Pressure Cardiovascular Class 2 870.1110 2026-04-30
DSA Cable, Transducer And Electrode, Patient, (Including Connector) Cardiovascular Class 2 870.2900 2026-04-30
KKX Drape, Surgical, Antimicrobial General, Plastic Surgery Class 2 878.4370 2007-12-14
OBJ Catheter, Ultrasound, Intravascular Cardiovascular Class 2 870.1200 2015-10-16
DXO Transducer, Pressure, Catheter Tip Cardiovascular Class 2 870.2870 2022-11-09
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2022-11-09
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2020-08-19
OBJ Catheter, Ultrasound, Intravascular Cardiovascular Class 2 870.1200 2020-08-19
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2007-12-14
OWB Interventional Fluoroscopic X-Ray System Radiology Class 2 892.1650 2017-10-06
OBJ Catheter, Ultrasound, Intravascular Cardiovascular Class 2 870.1200 2015-12-14
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2015-12-14
DXO Transducer, Pressure, Catheter Tip Cardiovascular Class 2 870.2870 2020-04-09
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2020-04-09
OWB Interventional Fluoroscopic X-Ray System Radiology Class 2 892.1650 2019-04-15
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2021-01-22
DSA Cable, Transducer And Electrode, Patient, (Including Connector) Cardiovascular Class 2 870.2900 2021-01-22
DSK Computer, Blood-Pressure Cardiovascular Class 2 870.1110 2021-01-22
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2016-07-15
OWB Interventional Fluoroscopic X-Ray System Radiology Class 2 892.1650 2014-06-03
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2012-11-08
OBJ Catheter, Ultrasound, Intravascular Cardiovascular Class 2 870.1200 2019-04-05
PDU Catheter For Crossing Total Occlusions Cardiovascular Class 2 870.1250 2016-12-06
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2016-12-06
MCW Catheter, Peripheral, Atherectomy Cardiovascular Class 2 870.4875 2015-05-21
DSK Computer, Blood-Pressure Cardiovascular Class 2 870.1110 2019-02-13
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2019-02-13
DSA Cable, Transducer And Electrode, Patient, (Including Connector) Cardiovascular Class 2 870.2900 2019-02-13
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2017-05-25
DSA Cable, Transducer And Electrode, Patient, (Including Connector) Cardiovascular Class 2 870.2900 2017-05-25

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Philips Medical Systems International BV
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3038281851 Philips Polska Sp. z o.o. Lodz Lodzkie, PL
3003584029 Braemar Manufacturing, LLC San Diego, CA, US
3042175841 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Best Noord-Brabant, NL
3008514395 Telcare, LLC Linwood, PA, US
3004961434 RESPIRATORY TECHNOLOGIES, INC. Plymouth, MN, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K771977 Instrumentation Laboratory CO CARDIAC OUTPUT COMPUTER MODEL 701 1978-01-03
K882805 Coopervision-Cilco CILCO VILLASENOR PACHYMETER 1988-08-12
K791040 Shimadzu Corp. SECTOR SCANNER, SDU-100, COMPUTERIZED 1979-10-04
K162372 Qt Ultrasound, LLC QT Ultrasound Breast Scanner-1 2017-06-06
K930964 Acuson Corp. ACUSON MODEL #29001 (DIAGNOSTIC ULTRASOUND DEVICE) 1994-10-26

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0003-2011 Verathon, Inc. 2
BVI 9600 Bladder Volume Instrument, Aorta Scan Mode The BladderScan BVI 9600 with AortaScan Mode is a user-selectable, dual-function ultrasound device that projects ultrasound energy either into the lower abdomen to obtain an image of the bladder for measuring bladder volume, or into the mid-abdomen to obtain an image of the abdominal aorta for aortic diameter measurements.
Z-0004-2011 Verathon, Inc. 2
AortaScan AMI 9700 The AortaScan AMI 9700 is an ultrasound device that projects ultrasound energy into the mid-abdomen to obtain an image of the abdominal aorta for aortic diameter measurements
Z-0005-2011 Verathon, Inc. 2
BladderScan BVM 9500 The BladderScan BVM 9500 is intended to project ultrasound energy through the lower abdomen to obtain an image of the bladder and measure urinary bladder volume and mass noninvasively.
Z-0027-2014 SonoSite, Inc. 2
P21x/5-1 MHz transducer, Part Number P07698-23 Product Usage: The P21x/5-1 MHz phased array transducer is designed for cardiac, abdominal and obstetric, TCD and orbital exams. It supports 2D with SonoMB Multi Beam Technology and Auto Gain capabilities, SonoHD Imaging Technology, Tissue Harmonic Imaging, M-Mode, Velocity Color Flow Doppler, Color Power Doppler (CDP), Pulsed Wave (PW), TDI Pulsed Wave, and Continuous Wave Doppler.
Z-0001-2026 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands 2
Allura Xper FD10C; Model Number: 722001; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2939520. Last updated year: 2026. Please use registration number 2939520 when referencing this establishment in official correspondence.
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